Platelet Function Monitoring in Patients With Acute Myocardial Infarction

This study is being done to learn more about platelet reactivity (how well the small cells in the bloodstream work) in people who undergo Percutaneous coronary intervention (PCI) for stable and unstable (acute myocardial infarction) indications. Stable means you have not demonstrated any acute injury to your heart prior to your PCI; unstable means you have demonstrated some acute injury to your heart prior to your PCI. The investigators intend to determine if there is a change in platelet reactivity from the time of PCI to 30days post-PCI and does this change differ depending upon the conduction in which you present for PCI. This is going to be done with a variety of platelet reactivity assays.

Study Overview

• Status: Completed
• Conditions: Acute Myocardial Infarction

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Seventy five subjects (25 patients undergoing elective PCI for stable CAD and 50 patients undergoing urgent PCI for AMI(25 receiving clopidogrel and 25 receiving prasugrel - as determined by the treating physicians)

Description

Inclusion Criteria:

• Patient >18 years old.
• Patient scheduled to undergo PCI for either stable CAD or AMI:
• Stable CAD defined as negative cardiac isoenzymes prior to the PCI as well as no resting ECG changes indicative of ACS.

• AMI defined as positive cardiac isoenzymes prior to the PCI and/or resting ECG changes indicative of ACS.

  3. Patients treated with a loading dose of clopidogrel at least 6 hours prior to the blood draw or on a maintenance dose of clopidogrel (of at least 75mg QD) for a minimum of 5 days.

Exclusion Criteria:

• Known allergies to aspirin, clopidogrel, or prasugrel
• Use of a glycoprotein (GP) IIb/IIIa inhibitor within 8 hours of the blood draw;
• Patient known to be pregnant or lactating;
• Patient with known history of bleeding diathesis or currently active bleeding;
• Platelet count <100,000/mm the day of the blood draw;
• Hematocrit <25% the day of the blood draw;
• On warfarin therapy at the time of the blood draw or the need for warfarin therapy in the subsequent month following the blood draw;
• Known blood transfusion within the preceding 10 days of the blood draw;
• Patient who has received NSAID (not including ASA) within preceding 24 hours of the blood draw;
• Patients presenting with cardiogenic shock;
• Any significant medical condition, which in the investigator's opinion may interfere with the patient's optimal participation in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Elective Cases; Patients with stable CAD undergoing PCI
AMI Cases treated with clopidogrel; Patient with AMI undergoing PCI
AMI Cases treated with prasugrel; Patients with AMI undergoing PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet function	The primary endpoint will be whether the results of platelet function assays used to measure response to clopidogrel and prasugrel therapy is similar amongst patients with stable CAD and those with AMI undergoing PCI. On-treatment platelet reactivity will be measured using the VerifyNow P2Y12 assay.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
On-treatment platelet reactivity	A secondary endpoint will be to determine on-treatment platelet reactivity at the same time points using: The vasodilator-stimulated phosphoprotein (VASP) phosphorylation assay; and/or; The Chrono-Log Lumi-Aggregometer, which measures platelet aggregation (via optical density or electrical impedance) in response to ADP stimulation.	30 days

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute
• Investigators: Principal Investigator: Ron Waksman, MD, Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: May 11, 2011
• First Submitted That Met QC Criteria: May 12, 2011
• First Posted (Estimate): May 13, 2011

Study Record Updates

• Last Update Posted (Estimate): November 1, 2013
• Last Update Submitted That Met QC Criteria: October 31, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Platelet reactivity
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: TIMING